Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies.
Children and adolescents with severe or relapsing major depressive disorder (MDD) may require long-term antidepressant use, but safety and tolerability data on long-term treatment are limited. In a randomized, placebo-controlled trial in children and another in adolescents, vortioxetine and placebo...
| Published in: | European Child & Adolescent Psychiatry Vol. 34; no. 4; pp. 1425 - 1435 |
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| Main Authors: | , , , , , , |
| Format: | research tables/charts randomized controlled trial Journal Article |
| Published: |
Springer Nature
Apr2025
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=184488750&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 184488750 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10188827 EJ3 jtl: European Child & Adolescent Psychiatry issn: 10188827 maglogo: N pubinfo: dt: Apr2025 vid: 34 iid: 4 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 184488750 179458387 184488750 184488750 10.1007/s00787-024-02560-1 184488750 ppf: 1425 ppct: 10 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Vortioxetine in children and adolescents with major depressive disorder: 6-month and 18-month open-label, flexible-dose, long-term extension studies. aug: au: DelBello, Melissa P. Findling, Robert L. Huss, Michael Necking, Oscar Petersen, Maria L. Schmidt, Simon N. Rosen, Monika affil: https://ror.org/01e3m7079 Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 260 Stetson Ave. Suite 3200, 45219, Cincinnati, Ohio, USA sug: subj: Depression Drug Therapy Depression Drug Therapy Piperidines Therapeutic Use Antidepressive Agents Therapeutic Use Drug Efficacy Evaluation Patient Safety Drug Tolerance Evaluation Human Funding Source Child Adolescence Male Female Randomized Controlled Trials Random Assignment Depression Symptoms Depression Prevention and Control Cognition Functional Status Antidepressive Agents Adverse Effects Nausea Headache Suicidal Ideation Scales Child: 6-12 years Adolescent: 13-18 years Male Female ab: Children and adolescents with severe or relapsing major depressive disorder (MDD) may require long-term antidepressant use, but safety and tolerability data on long-term treatment are limited. In a randomized, placebo-controlled trial in children and another in adolescents, vortioxetine and placebo groups showed improvement in MDD symptoms without statistically significant differences between groups. To gain insights on long-term safety and tolerability of vortioxetine in pediatric patients, participants from these two studies were enrolled in two long-term extension studies: 6 months (NCT02871297) followed by another 18 months (NCT03108625). Key safety measures included adverse events (AEs) and Columbia-Suicide Severity Rating Scale (C-SSRS); effectiveness measures included depression symptom severity, cognitive function, and overall functioning. Among the 662 patients in the 6-month extension, 61% experienced a treatment-emergent AE (TEAE), with the most common being nausea (20.8%); 2.1% had a serious AE (SAE), and 6% withdrew because of TEAEs. In the following 18-month extension (n = 94), 51% of patients experienced a TEAE, with the most common being headache (13.8%); no SAEs were reported. Based on the C-SSRS, 94% and 96% of patients reported no suicidal ideation or behavior in the 6- and 18-month studies, respectively. During the extension studies, patients continued to show improvement in depressive symptoms and cognitive and overall functioning, with > 50% of patients in remission at the end of each study, regardless of study treatment in the lead-in trial. Overall, vortioxetine remained well tolerated in pediatric patients with MDD who continued in the long-term extension studies with no observed increased risk in suicidal ideation. Trial registration: ClinicalTrials.gov ID: NCT02871297, August 18, 2016; ClinicalTrials.gov ID: NCT03108625, April 11, 2017. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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